Jobs for Veterans, Veteran Job Board | GiJobs.com

Post Jobs

Job Information

Merck Head of Pharmacovigilance Operations- #NCP1 in Kenilworth, New Jersey

Job Description

The AVP of Pharmacovigilance (PV) Operations is a global executive role that provides leadership in the areas of PV Operations, medical assessment, compliance, business capabilities, and innovation. The incumbent also oversees functional strategy planning and ensures effective development, implementation and execution of processes and standards to ensure patient safety. The AVP is accountable for activities pertaining to existing and evolving global regulations for the collection, processing, medical assessment and reporting of PV information to regulatory agencies and business partners. This role is responsible for providing leadership to the teams which support the end-to-end business processes for global PV activities and working cross-functionally to maintain standards for pharmacovigilance activities to ensure patient safety.

Organizational Relationships:

  • Reports to the R&D Strategic Operations VP

  • Resources Managed (FTEs)

  • Approximately 21 FTEs

  • Team members located at US, Switzerland and Singapore

Organization Scope:

AVP of PV Operations will manage the following direct reports:

  • PV Quality and Compliance Management Executive Director

  • Medical Safety Review and Device Reporting Executive Director

  • Regional PV Operations Executive Director

  • US PV Director

  • PV Process and Standards Director

Primary Responsibilities:

  • Create a compelling vision and strategy for the safety operations organization that energizes and motivates the team to aspire to excellence.

  • Create and maintain a culture of quality, compliance, and operational excellence that drives toward the highest level of quality and compliance for individual case and aggregate safety reporting in accordance with PV regulations to meet the needs of key stakeholders internally and externally.

  • Drive policy related to pharmacovigilance by combining a broad knowledge of PV regulations with an equally broad knowledge of functional areas within the company.

  • Establish a high performing case medical assessment and device reporting capability.

  • Represent the organization in key external discussions to shape global regulatory and safety science for the entire industry.

  • Responsible for responses to regulatory agency questions with regards to pharmacovigilance activities

  • Provide sponsorship and leadership to various important pharmacovigilance process, IT and quality initiatives.

  • Drive innovation in the safety system and business process space in partnership with IT, external IT vendors, and business process outsourcing organizations.

  • Define and monitor key performance indicators and ensure implementation of corrective and preventative actions as appropriate.

  • Build a team of leaders that can represent the company during regulatory inspections and that removes the dependency on one individual to successfully navigate an inspection.

  • Continual analysis of business processes to ensure minimization of compliance risk, optimal efficiency and maximization of business resources

  • Define strategic and forward-thinking approach to achieve global consistency of individual and aggregate report activities

  • Resolve complex technical, operational and financial problems

  • Maintain strong vendor relationships to ensure optimal performance and compliance with local and global PV regulations

  • Communicate potential safety issues to the Chief Safety Officer Partner across strategic operations to drive quality, compliance, and operational excellence into critical interfaces in R&D, Commercial, and Manufacturing.

  • Participate in Audits/inspections as subject matter expert for PV organization

Education Requirement:

  • Master's degree in health care/pharmaceutical related field or M.D. /D.O. / PhD or equivalent Ex US degree in Medicine

  • Preferred: Medical or relevant advanced degree 

Required:

  • Minimum of 15 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities

  • Minimum of 7 - 10 years of experience supervising/managing/leading

  • Organizational leadership skills in working with all levels of management and consulting with key business stakeholders

  • Demonstrated ability to innovate and drive successful transformational change in the PV space

  • Strong understanding of end to end pharmacovigilance processes related to individual case and aggregate safety reporting

  • Exceptional understanding and knowledge of individual case medical review and device reportability requirements.

  • Knowledge of global AE reporting requirements and relevant PV regulations

  • Regulatory Agency inspection experience

  • Proven enterprise leadership that goes beyond PV and R&D

  • Experience working cross culturally and actively supporting diversity

  • Problem solving, conflict resolution and critical thinking skills

  • Excellent presentation, writing and communication skills

#NewCo

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R61028

DirectEmployers